What does Joint Commission require if urine drug screens are performed in a behavioral health care facility?  

All organizations that perform urine drug testing must obtain the federally required CLIA^ license and abide by applicable Joint Commission standards. This is required even if the organization uses the test as a screen and then refers the sample to another laboratory for confirmatory testing. To determine which CLIA license is appropriate, it is first necessary to know the test complexity assigned by the FDA for the test system being used, which may be either waived^^, moderate, or high, based upon several factors. The test complexity may be obtained by contacting the manufacturer or locating the information in the package insert. It may also be searched at the following FDA web database.

The level of complexity then determines which CLIA license is required and the subsequent criteria which apply for various aspects of testing, such as inspection, personnel qualifications, and quality control. These requirements apply both to organizations that choose to provide the testing and to those organizations that are required to provide the testing by law and regulation. For clarity, the Joint Commission standards do not require organizations to perform urine drug testing.

For moderately complex urine drug testing, the requirements are different:

For moderately complex testing, organization's must fill out a separate application to request a biennial laboratory survey. Alternatively, an allowance from this requirement may be granted on a case by case basis under Joint Commission's "One Test Rule". An organization may formally request an exemption from the Joint Commission laboratory survey if it is performing only one moderately complex laboratory test and the organization can provide evidence of a state CLIA inspection every two years.